Clinical Project Manager III Job at werfen (Bedford)

Job Description

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Job Responsibility

Provide technical and team leadership to one or more small clinical project team(s), including planning, scheduling, and technical leadership within the project area. Coordinate roles and responsibilities within the clinical project team
Responsible for clinical project planning and scheduling, utilizing deliverable milestone methods and critical path scheduling, and developing task and project estimates. At the Program Manager's, Clinical Research managers, or Clinical Director's request provide a schedule and budget forecast for the project
Responsible for conducting regular clinical project team status meetings and reviews. Plan and schedule technical reviews at appropriate clinical project milestones. Ensures deliverables are completed and documented according to Good Clinical Practice and per design control
Responsible for coordination of clinical project resources to identify the root cause(s) of clinical project issues, and develop and manage a plan to fix, test, and implement an appropriate solution through completion. If needed, coordinate with cross-functional team resources to support root cause initiatives
Responsible for insuring clinical project risks, both technical risks and management risks, are identified and appropriate risk mitigation plans are developed and executed. Track and respond to risk triggers. Regularly assess and report the status of overall clinical project risk to the development project team and Clinical Research Manager
Creates and maintains Trial Master File(s) and corresponding Design Control files to current study ensuring accuracy
Responsible for communication within clinical project team, development project team, and to clinical program management and department management. Develop and implement a project communication plan
Coordinates with study sites and internal service suppliers (i.e., Biobanking, Field Service Engineers, etc.) to ensure project deliverables are completed correctly and on time or that services are provided in accordance with the project plan
Able to identify and obtain support to resolve project team conflict. As necessary, work with development project leader to resolve cross-team conflicts. Able to remove oneself from the problem. Fosters creative, professional climate that will maximize the contributions of the multi-disciplinary clinical project team members
Participates in activities focused on improving the efficiency and effectiveness of the product development processes and procedures
Participates in discussions with commercial functions (operations, regulatory, distribution, customer support, marketing, sales, service, affiliates, etc.) through established communication channels to support clinical project execution
Effectively interfaces with cross-functional groups through the organization to support company goals and objectives

Requirements

Medical Technologist degree or BS in STEM is preferred
Minimum of 4 years experience in clinical project or research management
Minimum of 2 years' experience leading CRAs
Experience in design and development of medical instrumentation
Clinical Research Associate (CRA) certification or equivalent certification in project management is desired
Working knowledge of Good Clinical Practice (GCP) / Good Study Practice (GSP) as described by US Food and Drug Administration (FDA), World Health Organization (WHO), International Conference on Harmonization (ICH), and International Standards Organization (ISO)
Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement
Problem solving, conflict management, listening, managing and measuring work
Strong project management skill set and familiarity with project management tools and techniques
Team player, self-motivated, perseverance
Strong oral and written communication skills

What we offer

medical insurance
dental insurance
vision insurance
401k plan retirement benefits with an employer match
paid vacation
paid sick leave

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Clinical Project Manager III

Job Description

Job Responsibility

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